FDA Greenlights Phase 2 Trial of TPX-115 Cell Therapy for Rotator Cuff Tears

Key Insights

• Tego Science receives FDA approval for Phase 2 clinical trial of TPX-115, an allogeneic dermal-derived fibroblast therapy for rotator cuff partial tears.
• The randomized, double-blind study will enroll 60 patients with Ellman grade 2 partial thickness rotator cuff tears across multiple U.S. medical institutions.
• The trial targets a $13.1 billion global market with no current cure, marking a significant advancement as the therapy moves directly to Phase 2 without Phase 1 trials in the U.S.

Tego Science has achieved a significant milestone as the U.S. Food and Drug Administration (FDA) approved its Investigational New Drug (IND) application for TPX-115, an innovative cell therapy targeting rotator cuff partial labral tears. The approval, received within approximately one month of submission, enables the company to proceed with Phase 2 clinical trials in the United States.

Trial Design and Patient Population

The upcoming study is designed as a randomized, double-blind, placebo-controlled trial that will span approximately 15 months. The trial will recruit around 60 adult patients across multiple U.S. medical institutions, focusing on individuals with MRI-confirmed Ellman grade 2 or ≤50% partial thickness rotator cuff tears (PTRCT) who have not responded to conservative treatment approaches.

TPX-115, an allogeneic dermal-derived fibroblast therapy, will be administered as a single intratendinous injection under ultrasound guidance. The study's primary endpoint will assess changes in the Constant-Murley Scale (CMS) score at 24 weeks post-treatment, providing a comprehensive evaluation of shoulder function and pain levels.

Development Status and Market Potential

The therapy has already demonstrated promising results in South Korea, where Tego Science has completed a Phase 1/2 study and is currently conducting Phase 2b/3 trials. The FDA's decision to allow direct progression to Phase 2 trials in the U.S. without requiring Phase 1 studies suggests confidence in the therapy's safety profile.

"In a 19 trillion won ($13.1 billion) market with no cure globally, an allogeneic cell therapy has entered phase 2 without phase 1," stated Tego Science CEO Jeon Sae-wha. "We will significantly expand our cell therapy business through the successful U.S. clinical trial of TPX-115."

Clinical Significance

The development of TPX-115 addresses a significant unmet medical need in orthopedics. Rotator cuff tears represent a common and debilitating condition that can severely impact patient quality of life and functionality. The progression of this cell therapy into Phase 2 trials marks an important step toward potentially providing a novel treatment option in a field where current therapeutic options are limited.